DeviceClearance

K964787

Substantially Equivalent

MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM

Applicant
Mardx Diagnostics, Inc.
Product code
LLL
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.